Etiological Study of Persistent Velopharyngeal Insufficiency in Children With Operated Velopalatine Cleft by Analysis of Velopharyngeal Motor Skills in Static and Dynamic MRI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- distance between the velar knee and the posterior pharyngeal wall
研究概览
简要总结
Velopharyngeal insufficiency is defined as the inability of the soft palate to isolate the nasopharynx from the oropharynx. It is a frequent sequela in patients with a velopalatine cleft despite anatomical restoration of the soft palate by intravelar veloplasty at 6 months. If rehabilitation by a speech therapist is not successful, a pharyngoplasty can be discussed. In the last ten years, MRI was used in dynamic and static way, to analyzed velopharyngeal muscles, in particular Levator Veli Palatini. MRI could be used to identify the etiology of VPI in those patients, and thus allow personalized rehabilitation and surgical management. The aim of this study is to examine the differences in velopharyngeal motricity as well as velar muscles morphology, positioning, and symmetry of children with repaired cleft palate with different degrees of severity of velopharyngeal insufficiency (VPI), and children with labial cleft (noncleft palate anatomy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 7 to 12 years with Isolated cleft lip
- •isolated velopalatal cleft
- •Without a diagnosis of syndromic cleft or Pierre Robin sequence
- •French speaking, and French is the native language
- •Operated with a cheiloplasty (for cleft lip) or an intravelar Veloplasty (according to Sommerlad) at the Amiens University Hospital
- •Whose follow-up is done at the Amiens University Hospital
排除标准
- •Refusal of the parents and/or the patient
- •With a contraindication to MRI
- •Whose follow-up was initiated in another center and/or whose surgery was performed in another center
- •Whose surgical schedule has not been followed
- •Patient with severe neurological or neuropsychiatric disorders or Severe speech and language delay not related to the cleft anatomy
- •Patients treated with fixed, non-removable orthodontic treatment.
研究组 & 干预措施
child with isolated operated velopalatal cleft with normal anatomy and soft VPI
干预措施: real time MRI (Other)
child with operated isolated labial cleft
干预措施: real time MRI (Other)
child with isolated operated velopalatal cleft with severe VPI ( IIB//IIM) and normal velum anatomy
干预措施: real time MRI (Other)
child with isolated operated velopalatal cleft with soft VPI (I/I-II) and abnormal velum anatomy
干预措施: real time MRI (Other)
结局指标
主要结局
distance between the velar knee and the posterior pharyngeal wall
时间窗: day 1
closure distance between the velar knee and the posterior pharyngeal wall
时间窗: day 1
ratio between the diameter of pharynx at rest and during phonation.
时间窗: day 1
次要结局
未报告次要终点